Peptide Graded

PT-141

Is PT-141 legal in the US?

Yes, FDA approved as bremelanotide (Vyleesi) for low desire in women before menopause. Not approved for men.

BSome human evidenceNot approvedas of 2026-10-26

PT-141 is the development code for bremelanotide, which the FDA approved in June 2019 as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Products sold online as PT-141 are not Vyleesi, are not approved by the FDA for any use, and are sold as research chemicals, most often to men, a population the drug was never approved for. 17

Premenopausal women with acquired, generalized hypoactive sexual desire disorder. This means low desire that developed after a period of normal desire. It occurs with any partner or situation and causes distress. A medical or psychiatric condition, relationship problems or another drug does not explain it. The drug is not approved for men or postmenopausal women. 17

Read the full PT-141 page

More on PT-141

Citations

  1. Dhillon 2019, Drugs: bremelanotide, first approval doi.org
  2. Spielmans 2024, J Sex Res: small effects, questionable outcomes, bremelanotide for HSDD doi.org
  3. Vyleesi (bremelanotide) prescribing information, DailyMed dailymed.nlm.nih.gov
  4. Sildenafil prescribing information, DailyMed dailymed.nlm.nih.gov
  5. Kingsberg 2019, Obstet Gynecol: bremelanotide for HSDD in premenopausal women, two randomized phase 3 trials (RECONNECT) doi.org
  6. Simon 2019, Obstet Gynecol: long-term safety and efficacy of bremelanotide, RECONNECT open-label extension doi.org
  7. FDA Drugs@FDA: Vyleesi NDA 210557 approval record accessdata.fda.gov
  8. Ann Pharmacother 2024: review of bremelanotide for HSDD doi.org
  9. J Clin Invest 2022: crossover fMRI study of bremelanotide in women with HSDD doi.org
  10. Diamond 2004, Int J Impot Res: intranasal PT-141 and erectile response in men doi.org
  11. Rosen 2004, Int J Impot Res: subcutaneous PT-141 in healthy men and men with an inadequate response to sildenafil doi.org
  12. Clayton 2016, Womens Health: bremelanotide phase 2b dose-finding trial in HSDD doi.org

Reference information only, not medical advice. Drawn from the PT-141 article, fact-checked against the cited sources. No dosing anywhere on this site.